Effectiveness of FACoT for Individuals Post Stroke

Recruiting

Trial Description

To develop and assess the effectiveness of a novel cognitive-functional intervention (FACoT) in occupational therapy for people after mild to moderate stroke.

Detailed Description

The consequences of mild stroke include cognitive, emotional and functional difficulties that lead to decreased quality of life. In Israel most rehabilitation centers do not provide treatment to this population who generally are high-functioning. A single-blind-randomized controlled trial will be conducted. Adults after mild to moderate stroke living in community from "Maccabi Health Services" and "shiba" will be invited to participate in this study. Inclusion and exclusion criteria: > 18 years, at least three years post stroke, severity mild to moderate (NIHSS≤10), independent prior to the stroke, can understand and speak Hebrew, with no other neurological or psychiatric conditions, without dementia or depression (GDS<10). Assessments will be administered pre and post the 10-week intervention and at follow-up 4-weeks later by assessors blind to the group allocation. Following the pre assessment, participants will be randomly allocated into two groups: treatment group will receive (FACoT) and the control group receiving standard care. Sample size: 46 patients - 23 in each group. the treatment sessions will include: functional activities, cognitive activities and strategies (pencil-pen treatment), and behavioural strategies

Description: treatment group will receive FACoT, that include one to one 10 treatment sessions. the treatment sessions will include: functional activities, cognitive activities and strategies (pencil-pen treatment), and behavioural strategies

Trial Design

Allocation: Randomized

Masking: Single Blind (Outcomes Assessor)

Purpose: Treatment

Endpoint: Efficacy Study

Intervention: Parallel Assignment

Outcomes

Type

Measure

Time Frame

Safety Issue

Primary

Change in scores of The Canadian Occupational Performance Measure (COPM)

Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- one month later)

No

Secondary

Change in scores of the Instrumental Activities of Daily Living (IADL) scale

Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- one month later)

No

Secondary

Change in scores of Reintegration to Normal Living Index (RNL)

Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- one month later)

No

Secondary

Change in scores of Short Form-12v2 Health Survey (SF-12v2)

Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- one month later)

No

Secondary

Change in scores of The Daily Living Self Efficacy scale (DLSES)

Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- one month later)

No

Secondary

Change in scores of Patient competency rating scale

Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- one month later)

No

Secondary

Change in scores of University of Rhode Island Change Assessment (URICA)

Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- one month later)

No

Secondary

Change in scores of Montreal Cognitive Assessment (MoCA)

Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- one month later)

No

Secondary

Change in scores of Trail making test (TMT)

Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- one month later)

No

Secondary

Change in scores of zoo-map

Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- one month later)

No

Secondary

Change in scores of Dysexecutive Questionnaire (DEX)

Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- one month later)

Professionals

Education

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This project is supported in part by the NIH Specialized Programs of Translational Research in Acute Stroke (SPOTRIAS) Network, and NINDS grant 3P50NS055977 to Washington University in St. Louis School of Medicine and UT Southwestern Medical Center.